Proposed Information Collection Activity; Comment Request, 59632-59633 [E8-23884]

Download as PDF 59632 Federal Register / Vol. 73, No. 197 / Thursday, October 9, 2008 / Notices call to order by the Council Chair and approval of previous Council minutes. The AHRQ director will present her update on current research, programs, and initiatives. The agenda will include a discussion on Patient-centered Health Care and Cost Effective Health Care by the Council. The final agenda will be available on the AHRQ Web site at http:// www.ahrq.gov no later than November 3, 2008. Dated: October 1, 2008. Carolyn M. Clancy, Director. [FR Doc. E8–23732 Filed 10–8–08; 8:45 am] BILLING CODE 4160–90–M DEPARTMENT OF HEALTH AND HUMAN SERVICES Administration for Children and Families Proposed Information Collection Activity; Comment Request Proposed Projects Title: State Developmental Disabilities Council 5-Year State Plan. OMB No.: 0980–0162. Description: A Plan developed by the State Council on Developmental Disabilities is required by federal statute. Each State Council on Developmental Disabilities must develop the plan, provide for public comments in the State, provide for approval by the State’s Governor, and finally submit the plan on a five-year basis. On an annual basis, the Council must review the plan and make any amendments. The State Plan will be used (1) By the Council as a planning document; (2) by the citizenry of the State as a mechanism for commenting on the plans of the Council; and (3) by the Department as a stewardship tool, for ensuring compliance with the Developmental Disabilities Assistance and Bill of Rights Act, as one basis for providing technical assistance (e.g., during site visits), and as a support for management decision making. Respondents: State Governments. ANNUAL BURDEN ESTIMATES Number of respondents Instrument State Developmental Disabilities Council 5–Year State Plan ......................... Estimated Total Annual Burden Hours: 20,185. In compliance with the requirements of Section 506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Administration for Children and Families is soliciting public comment on the specific aspects of the information collection described above. Copies of the proposed collection of information can be obtained and comments may be forwarded by writing to the Administration for Children and Families, Office of Administration, Office of Information Services, 370 L’Enfant Promenade, SW., Washington, DC 20447, Attn: ACF Reports Clearance Officer. E-mail address: infocollection@acf.hhs.gov. All requests should be identified by the title of the information collection. The Department specifically requests comments on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency’s estimate of the burden of the proposed collection of information; (c) Number of responses per respondent 55 the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology. Consideration will be given to comments and suggestions submitted within 60 days of this publication. Dated: October 3, 2008. Janean Chambers, Reports Clearance Officer. [FR Doc. E8–23881 Filed 10–8–08; 8:45 am] BILLING CODE 4184–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Administration for Children and Families Average burden hours per response 1 367 Total burden hours 20,185 OMB No.: 0980–0212. Description: For the program of the State Councils on Developmental Disabilities, funds are awarded to State agencies contingent on fiscal requirements in subtitle B of the Developmental Disabilities Assistance and Bill of Rights Act. The SF–269, ordinarily mandated in the revised OMB Circular A–102, provides no accounting breakouts necessary for proper stewardship. Consequently, the proposed streamlined form will substitute for the SF–269 and will allow compliance monitoring and proactive compliance maintenance and technical assistance. Respondents: State Councils and Designated State Agencies. Proposed Information Collection Activity; Comment Request Proposed Projects Title: Financial Status Reporting Form for State Councils on Developmental Disabilities Program. sroberts on PROD1PC70 with NOTICES ANNUAL BURDEN ESTIMATES Instrument Number of respondents Number of esponses per espondent Average burden hours per response Total burden hours Financial Status Reporting Form for State Councils on Developmental Disabilities Program .......................................................................................... 55 3 5.10 841.50 VerDate Aug<31>2005 21:01 Oct 08, 2008 Jkt 217001 PO 00000 Frm 00037 Fmt 4703 Sfmt 4703 E:\FR\FM\09OCN1.SGM 09OCN1 Federal Register / Vol. 73, No. 197 / Thursday, October 9, 2008 / Notices Estimated Total Annual Burden Hours: 841.50. In compliance with the requirements of section 506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Administration for Children and Families is soliciting public comment on the specific aspects of the information collection described above. Copies of the proposed collection of information can be obtained and comments may be forwarded by writing to the Administration for Children and Families, Office of Administration, Office of Information Services, 370 L’Enfant Promenade, SW., Washington, DC 20447, Attn: ACF Reports Clearance Officer. E-mail address: infocollection@acf.hhs.gov. All requests should be identified by the title of the information collection. The Department specifically requests comments on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency’s estimate of the burden of the proposed collection of information; (c) the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology. Consideration will be given to comments and suggestions submitted within 60 days of this publication. Dated: October 3, 2008. Janean Chambers, Reports Clearance Officer. [FR Doc. E8–23884 Filed 10–8–08; 8:45 am] Manufacturing Arrangements for Licensed Biologics’’ has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995. FOR FURTHER INFORMATION CONTACT: Jonna Capezzuto, Office of Information Management (HFA–710), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301–796–3794. SUPPLEMENTARY INFORMATION: In the Federal Register of November 19, 2007 (72 FR 65034), the agency announced that the proposed information collection had been submitted to OMB for review and clearance under 44 U.S.C. 3507. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. OMB has now approved the information collection and has assigned OMB control number 0910–0629. The approval expires on September 30, 2011. A copy of the supporting statement for this information collection is available on the Internet at http:// www.reginfo.gov/public/do/PRAMain. Dated: September 29, 2008. Jeffrey Shuren, Associate Commissioner for Policy and Planning. [FR Doc. E8–23907 Filed 10–8–08; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2008–N–0314] BILLING CODE 4184–01–P Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Recall Regulations DEPARTMENT OF HEALTH AND HUMAN SERVICES AGENCY: ACTION: Food and Drug Administration [Docket No. FDA–1999–D–0128] (formerly Docket No. 1999D–2013) Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Guidance for Industry: Cooperative Manufacturing Arrangements for Licensed Biologics AGENCY: Food and Drug Administration, sroberts on PROD1PC70 with NOTICES HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing that a collection of information entitled ‘‘Guidance for Industry: Cooperative VerDate Aug<31>2005 21:01 Oct 08, 2008 Jkt 217001 Food and Drug Administration, HHS. Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995. DATES: Fax written comments on the collection of information by November 10, 2008. ADDRESSES: To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX: 202–395–6974, or e-mailed to PO 00000 Frm 00038 Fmt 4703 Sfmt 4703 59633 baguilar@omb.eop.gov. All comments should be identified with the OMB control number 0910–0249. Also include the FDA docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Elizabeth Berbakos, Office of Information Management (HFA–710), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301–796–3792. SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance. FDA Recall Regulations—21 CFR Part 7—(OMB Control Number 0910–0249— Extension) Section 701 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 371) and part 7, subpart C (21 CFR part 7, subpart C), set forth the recall regulations (guidelines) and provide guidance to manufacturers on recall responsibilities. The guidelines apply to all FDA regulated products (i.e., food, including animal feed; drugs, including animal drugs; medical devices, including in vitro diagnostic products; cosmetics; and biological products intended for human use). These responsibilities include: (1) developing a recall strategy that requires time by the firm to determine the actions or procedures required to manage the recall (§ 7.42); (2) providing FDA with complete details of the recall including reason(s) for the removal or correction, risk evaluation, quantity produced, distribution information, firm’s recall strategy, a copy of any recall communication(s), and a contact official (§ 7.46); (3) notifying direct accounts of the recall, providing guidance regarding further distribution, giving instructions as to what to do with the product, providing recipients with a ready means of reporting to the recalling firm (§ 7.49); (4) submitting periodic status reports so that FDA may assess the progress of the recall (status report information may be determined by, among other things, evaluation return reply cards, effectiveness checks, and product returns) (§ 7.53); and (5) providing the opportunity for a firm to request in writing that FDA terminate the recall (§ 7.55). A search of the FDA database was performed to determine the number of recalls that took place during fiscal year 2007. The resulting number of recalls from this database search (2,166) is used in estimating the current annual reporting burden for this report. FDA E:\FR\FM\09OCN1.SGM 09OCN1

Agencies

[Federal Register Volume 73, Number 197 (Thursday, October 9, 2008)]
[Notices]
[Pages 59632-59633]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-23884]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Administration for Children and Families


Proposed Information Collection Activity; Comment Request

Proposed Projects

    Title: Financial Status Reporting Form for State Councils on 
Developmental Disabilities Program.
    OMB No.: 0980-0212.
    Description: For the program of the State Councils on Developmental 
Disabilities, funds are awarded to State agencies contingent on fiscal 
requirements in subtitle B of the Developmental Disabilities Assistance 
and Bill of Rights Act. The SF-269, ordinarily mandated in the revised 
OMB Circular A-102, provides no accounting breakouts necessary for 
proper stewardship. Consequently, the proposed streamlined form will 
substitute for the SF-269 and will allow compliance monitoring and 
proactive compliance maintenance and technical assistance.
    Respondents: State Councils and Designated State Agencies.

                                             Annual Burden Estimates
----------------------------------------------------------------------------------------------------------------
                                                                  Number of     Average  burden
                 Instrument                      Number of      responses  per     hours  per      Total burden
                                                respondents       respondent        response          hours
----------------------------------------------------------------------------------------------------------------
Financial Status Reporting Form for State                 55                3             5.10           841.50
 Councils on Developmental Disabilities
 Program....................................
----------------------------------------------------------------------------------------------------------------


[[Page 59633]]

    Estimated Total Annual Burden Hours: 841.50.
    In compliance with the requirements of section 506(c)(2)(A) of the 
Paperwork Reduction Act of 1995, the Administration for Children and 
Families is soliciting public comment on the specific aspects of the 
information collection described above. Copies of the proposed 
collection of information can be obtained and comments may be forwarded 
by writing to the Administration for Children and Families, Office of 
Administration, Office of Information Services, 370 L'Enfant Promenade, 
SW., Washington, DC 20447, Attn: ACF Reports Clearance Officer. E-mail 
address: infocollection@acf.hhs.gov. All requests should be identified 
by the title of the information collection.
    The Department specifically requests comments on: (a) Whether the 
proposed collection of information is necessary for the proper 
performance of the functions of the agency, including whether the 
information shall have practical utility; (b) the accuracy of the 
agency's estimate of the burden of the proposed collection of 
information; (c) the quality, utility, and clarity of the information 
to be collected; and (d) ways to minimize the burden of the collection 
of information on respondents, including through the use of automated 
collection techniques or other forms of information technology. 
Consideration will be given to comments and suggestions submitted 
within 60 days of this publication.

    Dated: October 3, 2008.
Janean Chambers,
Reports Clearance Officer.
 [FR Doc. E8-23884 Filed 10-8-08; 8:45 am]
BILLING CODE 4184-01-P